Wednesday, January 31, 2024

Review - HR 6607 Introduced – Federal Drug Manufacturing

Last month, Rep Schakowsky (D,IL) introduced HR 6607, the Affordable Drug Manufacturing Act of 2023. The bill would establish within HHS a new Office of Drug Manufacturing which would work to “to increase competition, lower prices, and address shortages in the market for prescription drugs, including insulin, asthma and chronic obstructive pulmonary disease (COPD) inhalers, naloxone, epinephrine auto-injectors, and antibiotics”. The legislation would authorize “such sums as may be necessary to carry out this section”.

Moving Forward

Schakowsky is a member of the House Energy and Commerce Committee to which this bill was assigned for consideration. This means that there could be sufficient influence to see this bill considered in Committee. Unfortunately for Schakowsky and her ten Democratic cosponsors, there would be unanimous opposition to the bill from the Committee’s Republicans. This bill will not be going anywhere in this session of Congress.

Commentary

When this bill was introduced, I noted that:

“I will be watching this bill for language and definitions that would include chemical manufacturing safety and security issues within the scope of responsibility of the proposed Office. I really do not expect to see either.”

I was right, this bill has nothing to do with chemical safety or security. In fact, having a government agency as the manufacturer of record would likely negate the coverage of many OSHA and EPA regulations as they do not apply to government agencies for the most part.

While Republicans will have a kneejerk reaction to this ‘socialist medical manufacturing’ proposal, something has to be done about bringing down the cost critical medications. Medicinal manufacturers have to recover their costs of development and that is certainly contributing to the costs. Unfortunately, this bill would probably have little effect on reducing or eliminating those costs as the developers would recoup those costs when they sold the government the rights to the manufacture the medications.

I think that the crafters of this bill made a serious political mistake when they included language that implied that the ODM would own the means of production (i.e.: “manufacture [emphasis added], or enter into contracts with entities” to manufacture. That idea would never fly with any Republican congresscritter, or even with many moderate Democrats. Paying manufacturers to make specific drugs for use by government agencies sounds a lot less ‘socialist’ and may have at least been considered for discussion.

In any case, this bill is not going anywhere, and it is really outside of the scope of things that I intend to cover here, so this will be my last word on the legislation.

 

For more information on the details of the proposed legislation, see my article at CFSN Detailed Analysis - https://patrickcoyle.substack.com/p/hr-6607-introduced - subscription required.

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